United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2022_register executive 2022-11-19 article Part II Rules and Regulations D09002ee1c7a0c827 D09002ee1c7a0cd2f United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule establishing additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List (FTL). The final rule adopts provisions requiring these entities to maintain records containing information on critical tracking events in the supply chain for these designated foods, such as initially packing, shipping, receiving, and transforming these foods. The requirements established in the final rule will help the Agency rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death resulting from foods being adulterated or misbranded. We are issuing this regulation in accordance with the FDA Food Safety Modernization Act (FSMA). 87 FR 70910 https://www.govinfo.gov/app/details/FR-2022-11-21/2022-24417 2022-24417 fr21no22-12 RIN 0910-AI44 4164-01-P Docket No. FDA-2014-N-0053 https://www.govinfo.gov/app/details/FR-2022-11-21/2022-24417 https://www.govinfo.gov/content/pkg/FR-2022-11-21/html/2022-24417.htm https://www.govinfo.gov/content/pkg/FR-2022-11-21/pdf/2022-24417.pdf Cosmetics Drugs Exports Food Labeling Imports Labeling Reporting and Recordkeeping Requirements 179 p. 70910 71088 87 FR 70910 Title 21 Part 1 21 CFR Part 1 RIN 0910-AI44 Requirements for Additional Traceability Records for Certain Foods; Federal Register Vol. 87, Issue RULE 2022-24417 II DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2023-01-20 Docket No. FDA-2014-N-0053 4164-01-P 2022-24417 Final rule.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule establishing additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List (FTL). The final rule adopts provisions requiring these entities to maintain records containing information on critical tracking events in the supply chain for these designated foods, such as initially packing, shipping, receiving, and transforming these foods. The requirements established in the final rule will help the Agency rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death resulting from foods being adulterated or misbranded. We are issuing this regulation in accordance with the FDA Food Safety Modernization Act (FSMA).

This rule is effective January 20, 2023. For the applicable compliance dates, see section VI "Effective and Compliance Dates" in the SUPPLEMENTARY INFORMATION section of this document. With regard to the final rule: Katherine Vierk, Office of Analytics and Outreach, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402- 2122, Katherine.Vierk@fda.hhs.gov. Cosmetics Drugs Exports Food Labeling Imports Labeling Reporting and Recordkeeping Requirements Requirements for Additional Traceability Records for Certain Foods, Katherine.Vierk@fda.hhs.gov PRAStaff@fda.hhs.gov https://cfsanappsexternal.fda.gov/scripts/FDARiskRankingModelforFoodTracingfinalrule/ https://precision.fda.gov/challenges/13 https://www.fao.org/fao-who-codexalimentarius/sh-proxy/tr/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXG%2B60-2006%252FCXG_060e.pdf https://www.fao.org/policy-support/tools-and-publications/resources-details/en/c/1412247/ https://www.fda.gov/about-fda/domestic-mous/mou-225-09-0008 https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations https://www.fda.gov/food/cfsan-risk-safety-assessments/joint-fda-health-canada-quantitative-assessment-risk-listeriosis-soft-ripened-cheese-consumption https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-reports-studies https://www.fda.gov/media/102784/download https://www.fda.gov/media/117526/download https://www.fda.gov/media/131229/download https://www.fda.gov/media/139868/download https://www.fda.gov/media/142280/download https://www.fda.gov/media/142281/download https://www.fda.gov/media/142282/download https://www.fda.gov/media/142283/download https://www.fda.gov/media/145050/download https://www.fda.gov/media/155402/download https://www.fda.gov/media/80637/download https://www.fda.gov/media/85043/download https://www.fda.gov/media/99911/download https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-seafood-list https://www.fda.gov/science-research/peer-review-scientific-information-and-assessments/completed-peer-reviews https://www.regulations.gov www.fda.gov Vol. 87, no. 223 Office of the Federal Register, National Archives and Records Administration 2022-11-21 continuing daily deposited born digital 509 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2022-11-21 P0b002ee1b886a590 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr21no22 https://www.govinfo.gov/app/details/FR-2022-11-21 https://www.govinfo.gov/content/pkg/FR-2022-11-21/pdf/FR-2022-11-21.pdf https://www.govinfo.gov/content/pkg/FR-2022-11-21/xml/FR-2022-11-21.xml fdlp 70701 71201 DGPO 2022-11-19 2024-05-29 FR-2022-11-21 machine generated eng FR FR-2022-11-21 87 223